InSite Vision Receives Regulatory Approval for AzaSite® in Canada
ALAMEDA, Calif., Mar 31, 2009 (BUSINESS WIRE) -- InSite Vision Incorporated (AMEX:ISV) today announced that the Therapeutic Products Directorate (TPD) of Health Canada has approved the company's new drug submission (NDS) for AzaSite (azithromycin ophthalmic solution) 1% for the treatment of bacterial conjunctivitis (pink eye) in adults and children one year and older. AzaSite is formulated with DuraSite®, InSite Vision's patented drug delivery vehicle that enhances the retention time of the antibiotic on the surface of the eye, offering the benefit of a less frequent and more convenient dosing regimen.
AzaSite was approved for treatment of bacterial conjunctivitis by the U.S. Food and Drug Administration (FDA) in April 2007, and commercially launched in August 2007 by Inspire Pharmaceuticals, a biopharmaceutical company based in Durham, North Carolina and exclusive licensee of AzaSite in the U.S. and Canada. Under the terms of the companies' agreement, the NDS will transfer to Inspire Pharmaceuticals and Inspire will be responsible for marketing AzaSite in Canada.
"Canadian approval of AzaSite is an important milestone for InSite, furthering our efforts to reach more patients with a product that is a clinically proven, safe and effective treatment for conjunctivitis and typically requires less than half the dosing of other ocular antibiotics," commented Lou Drapeau, InSite's Chief Executive Officer. "We are focused on supporting our marketing partner, Inspire Pharmaceuticals, on the expansion of AzaSite sales and we look forward to working closely with them to capture additional value for the product throughout North America."
Canadian regulatory approval was based on two Phase 3 clinical trials of AzaSite which demonstrated that AzaSite was safe and effective. Enrolling more than 1400 patients with bacterial conjunctivitis in the U.S. and Latin America, AzaSite was administered twice daily on the first two days, then once daily on days 3-5. Results from the Phase 3 pivotal trials demonstrated that AzaSite provided clinically and statistically significant improvements in clinical resolution of symptoms and bacterial eradication compared to placebo; and was equivalent in clinical resolution and bacterial eradication when compared to tobramycin administered four times a day for five days.
